| Date |
Drug/Device |
Alert |
| 7.21.10 |
Coumadin 1 mg Tablet Blister Packs Recall |
DRUG ALERT |
| 7.21.10 |
Air- or Gas-Pressurized Spray Devices - Risk of Air or Gas Embolism |
DEVICE CAUTIONARY NOTICE |
| 7.21.10 |
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury |
DRUG WARNING |
| 6.07.10 |
Intravenous Medications Manufactured by Claris:
Recall Due to Contamination of Products |
DRUG WARNING |
| 5.26.10 |
Drug Safety Labeling Changes ‐ Proton Pump Inhibitors (PPI) |
DRUG CAUTIONARY NOTICE |
| 5.25.10 |
Drug Safety Labeling Changes ‐ Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen) |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Zonegran (zonisamide) capsules |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Tisseel (fibrin sealant) |
DRUG CAUTIONARY NOTICE |
| 5.14.10 |
Class I Recall: GE Healthcare Aisys and Avance Anesthesia Systems |
DEVICE WARNING |
| 5.06.10 |
Baxter Colleague Infusion Pumps: FDA Ordering Recall |
DEVICE CAUTIONARY NOTICE |
| 5.06.10 |
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Boniva (ibandronate sodium) tablets |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Coumadin (warfarin sodium) tablets and injection |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Kenalog (triamcinolone acetonide) injectable suspension |
DRUG CAUTIONARY NOTICE |
| 2.19.10 |
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp Drug Safety Communication |
DRUG CAUTIONARY NOTICE |
| 1.21.09 |
McNeil Consumer Healthcare OTC products:
Recall – 12/09 recall of Tylenol arthritis caplets now expanded to multiple other products |
DRUG CAUTIONARY NOTICE |
| 1.06.09 |
Thermoflect Blankets and product line –
Recall: Products are not to be used in MR environment |
DEVICE CAUTIONARY NOTICE |
| 1.06.09 |
Tylenol Arthritis Pain Caplet 100 count: Recall of all lots due to reports of odor associated with nausea, vomiting and diarrhea |
DRUG CAUTIONARY NOTICE |
| 12.22.09 |
Drug Safety Labeling Changes – Actiq (fentanyl citrate) oral transmucosal |
DRUG WARNING |
| 12.22.09 |
Drug Safety Labeling Changes – Qualaquin (quinine sulfate) 324 mg capsules |
DRUG WARNING |
| 12.10.09 |
Norpramin (desipramine hydrochloride) –
Risk of Sudden Death and Cardiac Dysrhythmias |
DRUG WARNING |
| 12.10.09 |
Voltaren Gel (diclofenac sodium topical gel) –
Hepatic Effects Labeling Change: Cases of Drug |
DRUG WARNING |
| 12.10.09 |
Steris System 1 Processor: FDA Notice and Recommendations-Unapproved Device With Potential for Improper Sterilization and Disinfection |
DEVICE CAUTIONARY NOTICE |
| 12.03.09 |
Stryker Operating Room System II Surgical Navigation System: Recall due to potential for the navigation PC SPC-1 component to stop working |
DEVICE WARNING |
| 11.07.09 |
Synthes Synex II Central Body Components ‐‐
Class I Recall Due to Potential for Hazard to Patients |
DEVICE ALERT - CLASS I RECALL |
| 10.30.09 |
Drug Safety Labeling Changes – Flector Patch (diclofenac epolamine) 1.3% topical patch Voltaren Gel (diclofenac sodium) 1 % topical gel |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – OxyContin (oxycodone hydrochloride) controlled-release tablets |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – DepoDur (morphine sulfate extended-release) liposome injection |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes –
Tramadol hydrochloride tablets:
- Ultracet (tramadol HCl/acetaminophen) tablets
- Ultram (tramadol hydrochloride) tablets
|
DRUG CAUTIONARY NOTICE |
| 10.26.09 |
Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials Recall |
DRUG CAUTIONARY NOTICE |
| 10.8.08 |
Heparin: Change in Reference Standard – The change will result in 10% reduction in the potency of the heparin marketed in the U.S. |
DRUG CAUTIONARY NOTICE |
| 9.28.09 |
Medtronic Intrathecal Catheters and Revision Kits --
Class I Recall Due to Possibility of Obstruction or Disruption of Therapy |
DEVICE WARNING |
| 9.17.09 |
Promethazine Hydrochloride Injection ‐ Boxed Warning Describing Severe Tissue Injury, Including Gangrene, After IV Administration of Drug |
DRUG CAUTIONARY NOTICE |
| 9.12.09 |
Drug Safety Labeling Changes – Wellbutrin (bupropion hydrochloride) Tablets and Sustained‐Release Tablets |
DRUG CAUTIONARY NOTICE |
| 8.10.09 |
Colchicine (marketed as Colcrys) - Two Previously Uncharacterized Safety Concerns Associated With the Use of Colchicine |
DRUG CAUTIONARY NOTICE |
| 7.7.09 |
Arthroscopic Shavers: Reports Describing Instances of Tissue Remaining Within Arthroscopic Shavers Even After Cleaning Process Completed |
DEVICE CAUTIONARY NOTICE |
| 7.7.09 |
Propoxyphene-Containing Products: FDA Taking Actions to Reduce Risk of Overdose Because of Data Linking Propoxyphene and Fatal Overdoses |
DRUG CAUTIONARY NOTICE |
|
7.1.09 |
Zolendronic Acid (Marketed as Reclast®):
Renal Impairment and Acute Renal Failure |
DRUG WARNING |
| 7.1.09 |
Quinine Sulfate (Marketed as Qualaquin®):
Off-Label (Not Approved by FDA) Use of Quinine |
DRUG WARNING |
| 6.18.09 |
Cefepime® (Maxipime) Update of Ongoing Safety Review - FDA Determined That Data Reviews Do Not Indicate a Higher Rate of Death in Cefepime®-Treated Patients |
DRUG CAUTIONARY NOTICE |
| 4.14.09 |
FDA Requiring Submission of Safety and Effectiveness Information for Certain Class III Devices |
REGULATORY NOTICE |
| 4.06.09 |
FDA Orthopaedic and Rehabilitation Devices Panel Finds Stryker Biotech’s PMA Application for OP‐1 Putty “Not Approvable” |
REGULATORY NOTICE |
| 3.13.09 |
Transdermal Drug Patches with Metallic Backings:
Risk of Burns During MRI Scans |
DRUG CAUTIONARY NOTICE |
| 3.13.09 |
FDA Classifies Recent Urgent Device Correction on Baxter’s Colleague Infusion Pump as a Class I Recall |
DEVICE WARNING |
| 3.10.09 |
FDA Has Issued Warning Letter Addressing Improper Promotion of the Valeo™‐C VBR Device |
REGULATORY NOTICE |
| 2.17.09 |
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs |
REGULATORY NOTICE |
| 2.02.09 |
ETHEX Corporation and Ther-RX Corporation Issue Nationwide Voluntary Recalls of Products Due to Oversized Tablets and Potential for Overdosage |
DRUG WARNING |
| 1.12.09 |
Important Change to Prescribing Information for Fluoroquinolones–Addition of Boxed Warning and Medication Guide Regarding Tendinitis and Tendon Rupture |
DRUG CAUTIONARY NOTICE |
| 1.07.09 |
Innohep® (tinzaparin sodium) Dear Healthcare Professional Letter Issued Regarding Increased Risk of Death in Renal Impaired Elderly |
DRUG CAUTIONARY NOTICE |
| 1.06.09 |
Hydromorphone tablets [ETHEX] recalled due to oversized tablets and potential for over dosage |
DRUG WARNING |
| 12.18.08 |
Class I Recall: HLX8 Device |
DEVICE CAUTIONARY NOTICE |
| 11.13.08 |
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), Zoledronic acid (Reclast, Zometa) |
DRUG CAUTIONARY NOTICE |
| 11.13.08 |
Important Change in the Levaquin® (levofloxacin) Complete Prescribing Information – Addition of Boxed Warning and Medication Guide Regarding Tendinitis and Tendon Rupture |
DRUG CAUTIONARY NOTICE |
| 11.12.08 |
ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets |
DRUG WARNING |
| 11.11.08 |
Important Revisions to the Prescribing Information for
Heparin Sodium Injection (Preservative Free and Preserved with Parabens) |
DRUG WARNING |
| 11.11.08 |
Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade |
DRUG CAUTIONARY NOTICE |
| 11.03.08 |
Important Change in the Avelox® (moxifloxacin hydrochloride) and Cipro® (ciprofloxacin) Complete Prescribing Information – Addition of Boxed Warning and Medication Guide Regarding Tendinitis and Tendon Rupture |
DEVICE CAUTIONARY NOTICE |
| 10.03.08 |
Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit - Class I Recall |
DEVICE WARNING |
| 9.09.08 |
Disposable Battery Operated Lavage Systems (BOLS) |
DEVICE CAUTIONARY NOTICE |
| 9.09.08 |
Tumor necrosis factor-alpha blockers (TNF blockers),
Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) |
DRUG CAUTIONARY NOTICE |
| 7.16.08 |
Preliminary Public Health Notification (FDA):
Possible Malfunction of Electronic Medical Devices Caused by Computer Tomography (CT) Scanning |
DEVICE CAUTIONARY NOTICE |
| 7.03.08 |
FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion |
BIOLOGICS ALERT |
| 7.01.08 |
Important Revisions to the Prescribing Information for
Ultram ER ® (tramadol HCl) Extended-Release Tablets |
DRUG WARNING |
| 7.01.08 |
Important Revisions to the Prescribing Information for
Halcion ® (triazolam) Tablets |
DRUG WARNING |
| 7.01.08 |
Important Revisions to the Prescribing Information for
Duragesic ® (fentanyl) Transdermal System |
DRUG WARNING |
| 6.16.08 |
ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets |
DRUG ALERT |
| 6.10.08 |
Morphine Sulfate 60 mg Extended Release Tablets –
Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness |
DRUG ALERT |
| 6.10.08 |
Remicade, Enbrel, Humira and Cimzia-
FDA Investigating Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults |
DRUG CAUTIONARY NOTICE |
| 5.23.08 |
Trasylol (aprotinin injection)-To Be Removed From All Hospital Pharmacies, Available Only Under Limited Use Agreement Access |
DRUG WARNING |
| 5.05.08 |
Enbrel (etanercept) – Prescribing Information Revised to Include a Boxed Warning Regarding the Risk of Infection, Including Tuberculosis |
DRUG WARNING |
| 4.03.08 |
Covidien Heparin Sodium USP Pre-filled Syringes–
Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant |
DRUG ALERT |
| 3.24.08 |
Medtronic Neuromodulation Implantable Infusion Pumps: Class I Recall - Reports of Inflammatory Mass Formations |
DEVICE ALERT |
| 2.24.08 |
B. Braun Heparin Sodium Injection Solutions –
Recall Due to Heparin-like Contaminant |
DRUG ALERT |
| 2.29.08 |
Heparin Sodium Injection: Recall of Multi-dose and Single-dose Vials |
DRUG ALERT |
| 2.27.08 |
Epidural Conduction Device Fractures and Complications of Retained Fragments |
DEVICE CAUTIONARY NOTICE |
| 2.27.08 |
Preventing Accidents and Injuries in the MRI Suite |
DEVICE CAUTIONARY NOTICE |
| 2.20.08 |
Fentanyl Transdermal Patches – Recall Due to Gel Leak That May Lead to Respiratory Depression and Overdose |
DRUG WARNING |
| 2.20.08 |
Duragesic 25 mcg/hr (fentanyl transderman system) Pain Patches – Recall Because Some Patches May Have a Cut Edge |
DRUG WARNING |
| 2.12.08 |
Heparin Sodium Injection – Serious Adverse Events Reported in Patients Receiving Bolus Doses of Medication |
DRUG ALERT |
| 2.12.08 |
Important Revisions to the Prescribing Information for Dalmane® (flurazepam hydrochloride) Capsules |
DRUG WARNING |
| 2.12.08 |
Important Revisions to the Prescribing Information for Lodine® (etodolac capsules and tablets) |
DRUG WARNING |
| 2.12.08 |
Important Revisions to the Prescribing Information for Ambien® (zolpidem tartrate) Tablets |
DRUG WARNING |
| 2.12.08 |
Important Revisions to the Prescribing Information for
Cialis® (tadalafil) Tablets
Levitra® (vardenafil hydrochloride) Tablets
Viagra® (sildenafil citrate) Tablets |
DRUG WARNING |
| 2.12.08 |
Important Revisions to the Prescribing Information for Doral® (quazepam tablets, USP) |
DRUG WARNING |
| 2.11.08 |
Intravenous Colchicine – Product Associated With Fatal Effects Including Cardiac Events And Organ Failure |
DRUG CAUTIONARY NOTICE |
| 2.11.08 |
Botox And Botox Cosmetic (Botulinum toxin Type A) And Myobloc (Botulinum toxin Type B) – Reports of Respiratory Compromise And Death |
DRUG CAUTIONARY NOTICE |
| 2.07.08 |
Medtronic Inc. SynchroMed EL Implantable Infusion Pump Class I Recall |
DEVICE WARNING |
| 2.07.08 |
Antiepileptic Drugs – FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation |
DRUG WARNING |
| 1.23.08 |
Heparin and Normal Saline Pre-Filled Flushes-Nationwide Recall Because One Lot Was Contaminated With Bacteria |
DRUG ALERT |
| 1.23.08 |
Heparin Sodium Injection 1000 units/ml Recalled Due to Multiple Adverse Reactions Reported |
DRUG WARNING |
| 1.14.08 |
Alaris Pump Module – Worldwide Recall Because The Units May Contain Misassembled Occluder Springs |
DEVICE WARNING |
| 1.14.08 |
Bisphosphonates – Possible Cause Of Severe And Sometimes Incapacitating Bone, Joint, and/or Muscle Pain |
DEVICE WARNING |
| 1.14.08 |
Fentanyl Transdermal System - Updated Information On Appropriate Prescribing, Dose Selection, and Safe Use |
DEVICE WARNING |
| 11.26.07 |
Cefepime® (Maxipime) – Early Communication About An Ongoing Safety Review |
UPDATED WARNINGS and PRECAUTIONS |
| 11.16.07 |
Cefazolin for Injection, USP and Dextrose Injection, USP |
UPDATED WARNINGS and PRECAUTIONS |
| 11.16.07 |
Vancomycin Hydrochloride® (vancomycin hydrochloride) Injection, Solution for Intravenous Use Only |
UPDATED WARNINGS and PRECAUTIONS |
| 11.16.07 |
Soma® (carisoprodol) Tablets for Oral Use |
UPDATED WARNINGS and PRECAUTIONS |
| 11.16.07 |
Levaquin® (levofloxacin) Tablets and Oral Solution
Levaquin® (levofloxacin) Injection for Intravenous Use
Levaquin® (levofloxacin in 5% dextrose) Injection for Intravenous Use |
UPDATED WARNINGS and PRECAUTIONS |
| 11.16.07 |
Cefuroxime for Injection, USP and Dextrose Injection, USP |
UPDATED WARNINGS and PRECAUTIONS |
| 10.12.07 |
Antidepressant Medications – Updated Product Labeling To Include New Warnings About Suicidal Thinking and
Behavior In Young Adults |
UPDATED PRODUCT LABELING |
| 10.10.07 |
Early Communication Issued Regarding Atrial Fibrillation With Oral And Intravenous Bisphosphonates |
EARLY COMMUNICATION |
| 9.20.07 |
Norpramin® (desipramine hydrochloride tablets, USP) |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Feldene® (piroxicam) Capsules |
UPDATED NSAID
MEDICATION GUIDE |
| 9.20.07 |
Remeron® (mirtazapine) Tablets, RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Voltaren® (diclofenac sodium enteric-coated tablets) |
UPDATED NSAID
MEDICATION GUIDE |
| 9.20.07 |
Ceftin® Tablets (cefuroxime axetil tablets), Ceftin® for Oral Suspension (cefuroxime axetil powder for oral suspension) |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Nortriptyline Hydrochloride® Oral Solution, USP |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Rocephin® (ceftriaxone sodium) for injection |
UPDATED PRESCRIBING INFORMATION |
| 9.20.07 |
Daypro Alta® (oxaprozin potassium) Tablets |
UPDATED NSAID
MEDICATION GUIDE |
| 9.20.07 |
Oruvail® Extended-Release (ketoprofen extended-release) Capsule, Orudis® (ketoprofen) Capsule) |
UPDATED NSAID
MEDICATION GUIDE |
| 9.20.07 |
Seroquel® (quetiapine fumarate) Tablets |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Drug Cuts NSAID Users' Risk of Hospitalization for Peptic Ulcer by More than Half |
NEW AHRQ STUDY FINDINGS |
| 9.20.07 |
Pamelor® (nortriptyline HCl) Capsules and Oral Solution, USP |
UPDATED WARNINGS and PRECAUTIONS |
| 9.20.07 |
Tofranil-PM® (imipramine pamoate capsules) |
UPDATED WARNINGS and PRECAUTIONS |
| 9.13.07 |
Fentora® (fentanyl buccal tablet) |
UPDATED WARNINGS and PRECAUTIONS |
| 9.6.07 |
Lyrica® (pregabalin) Capsules |
UPDATED WARNINGS,
PRECAUTIONS and ADVERSE REACTIONS |
| 9.6.07 |
Levaquin® (levofloxacin) Tablets and Oral Solution, Levaquin® (levofloxacin) Injection, Levaquin® (levofloxacin in 5% dextrose) Injection) |
UPDATED WARNINGS and
PRECAUTIONS |
| 9.6.07 |
Floxin® (ofloxacin tablets) Tablets |
UPDATED WARNINGS and
PRECAUTIONS |
| 9.6.07 |
Cipro I.V.® (ciprofloxacin), Cipro® (ciprofloxacin hydrochloride) Tablets, Cipro® (ciprofloxacin) Oral Suspension, Cipro XR®
(ciprofloxacin extended-release tablets) |
UPDATED WARNINGS and
PRECAUTIONS |
| 9.6.07 |
Duricef® (cefadroxil monohydrate, USP) Powder, for Suspension, Duricef® (cefadroxil monohydrate, USP) Tablets and Capsules |
UPDATED WARNINGS and
PRECAUTIONS |
| 9.6.07 |
Bactrim® (sulfamethoxale and trimethoprim DS [double strength]) Tablets |
UPDATED WARNINGS and
PRECAUTIONS |
| 8.21.07 |
Codeine Products Used by Nursing Mothers |
UPDATED PRESCRIBING
INFORMATION and PUBLIC HEALTH ADVISORY |
| 8.21.07 |
Warfarin (marketed as Coumadin®) |
UPDATED CLINICAL PHARMACOLOGY, PRECAUTIONS,
and DOSAGE AND ADMINISTRATION |
| 8.15.07 |
Baxter Healthcare Corporation Recalls Infusion Pumps |
RECALL |
| 8.15.07 |
Plavix® (clopidogrel bisulfate tablets) |
UPDATED WARNINGS and
PRECAUTIONS |
| 8.15.07 |
Naprelan® (naproxen sodium) Controlled Release Tablets |
UPDATED NSAID
MEDICATION GUIDE |
| 8.15.07 |
Levaquin® (levofloxacin) Tablets and Oral Solution, Levaquin® (levofloxacin) Injection, Levaquin® (levofloxacin in 5% dextrose) Injection |
UPDATED WARNINGS and
PRECAUTIONS |
| 8.15.07 |
MS Contin® (morphine sulfate controlled-release) Tablets |
UPDATED PRECAUTIONS
and ADVERSE REACTIONS |
| 8.15.07 |
Floxin® Tablets (ofloxacin tablets) |
UPDATED WARNINGS and
PRECAUTIONS |
| 8.15.07 |
Lovenox® (enoxaparin sodium injection) for Subcutaneous and Intravenous Use |
UPDATED CONTRAINDICATIONS, WARNINGS & PRECAUTIONS, ADVERSE REACTIONS and USE IN SPECIFIC POPULATIONS |
| 8.2.07 |
EC-Naprosyn® (naproxen delayed-release tablets), Naprosyn® (naproxen tablets), Anaprox/Anaprox DS® (naproxen sodium tablets), Naprosyn® (naproxen suspension) |
UPDATED MEDICATION GUIDE |
| 8.2.07 |
Actonel® (risedronate sodium tablets) |
UPDATED PRECAUTIONS,
ADVERSE REACTIONS and PATIENT PACKAGE INSERT |
| 8.2.07 |
Ativan® (lorazepam) Tablets |
UPDATED CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS |
| 6.21.07 |
Diprivan® (propofol)- Reports of Patients Experiencing Chills, Fever, and Body Aches Shortly After Receiving Propofol For Sedation Or General Anesthesia |
WARNING |
| 5.30.07 |
Integra LifeSciences EnDura No-React Dural Substitute |
RECALL |
| 5.24.07 |
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging: FDA Requests That A Boxed Warning and New Warnings Be Added To Prescribing Information |
WARNING |
| 5.14.07 |
OxyContin, Illegal Promotion by Manufacturer May Cause Health Risks for Consumers |
WARNING |
| 5.10.07 |
Antidepressant Medications – FDA Proposes That Manufacturers Update Product Labeling To Include New Warnings About Suicidal Thinking and Behavior
In Young Adults |
UPDATED PRESCRIBING WARNING |
| 4.19.07 |
FDA Seizes All Medical Products from N.J. Device Manufacturer (Shelhigh, Inc.) for Significant Manufacturing Violations |
SIGNIFICANT MANUFACTURING DEFICIENCIES |
| 4.17.07 |
Zanaflex® [tizanidine HCL] |
UPDATED PRESCRIBING INFORMATION |
| 4.11.07 |
Trimethobenzamide Hydrochloride Suppository Drug Products [Tigan®, Tebamide®, T-Gen®, Trimazide® and Trimethobenz®] |
FDA ORDERS MANUFACTURER TO CEASE PRODUCTION |
| 3.29.07 |
Smith & Nephew Radio Frequency (RF) Denervation Probes |
RECALL |
| 3.22.07 |
Sedative-hypnotic drug products: Labeling strengthened to include warnings about risk of severe allergic reactions and sleep-driving |
UPDATED WARNINGS |
| 3.16.07 |
Erythropoiesis Stimulating Agents (ESA) [Aranesp® (darbepoetin), Epogen® (epoetin alfa) and Procrit® (epoetin alfa)] |
UPDATED WARNINGS |
| 3.2.07 |
Wellbutrin® (bupropion hydrochloride) Tablets and Sustained-Release Tablets |
UPDATED PRECAUTIONS & ADVERSE REACTIONS |
| 3.2.07 |
Mobic® (meloxicam) Tablets and Oral Suspension |
UPDATED WARNINGS, PRECAUTIONS & ADVERSE REACTIONS |
| 3.2.07 |
Toradol® (ketorolac tromethamine) Tablets |
UPDATED PRESCRIBING INFORMATION AND MEDICATION GUIDE |
| 2.21.07 |
Erythropoiesis Stimulating Agents (ESA) [Aranesp® (darbepoetin), Epogen® (epoetin alfa) and Procrit® (epoetin alfa)] |
CLINICAL TRIAL RESULTS: MAY CAUSE HARM IN CANCER PATIENTS NOT CURRENTLY ON CHEMOTHERAPY |
| 2.14.07 |
Activella® (estradiol/norethindrone acetate) tablets |
UPDATED WARNINGS, PRECAUTIONS & ADVERSE REACTIONS |
| 2.14.07 |
Fosamax® (alendronate sodium) Tablets and Oral Solution Fosamax Plus D® (alendronate sodium/cholecalciferol) Tablets |
UPDATED ADVERSE REACTIONS |
| 2.14.07 |
Depakote® (divalproex sodium coated particles) Sprinkle Capsules |
UPDATED PACKAGE INSERT/ADMINISTRATION GUIDE |
| 1.16.07 |
Vicoprofen® (hydrocodone bitartrate and ibuprofen) tablets |
UPDATED CONTRAINDICATIONS, WARNINGS & PRECAUTIONS |
| 1.16.07 |
Coumadin® Tablets (warfarin sodium tablets, USP) Crystalline Coumadin® for Injection (warfarin sodium for injection, USP) |
UPDATED BOXED WARNING |
| 1.4.07 |
Update on MRI Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy |
DANGERS FOR PATIENTS WITH MODERATE TO END-STAGE KIDNEY DISEASE |
| 1.4.07 |
Rituxan® (Rituximab) - Life-Threatening Brain Infection in Patients with Systemic Lupus Erythematosus |
SAFETY WARNING AFTER TWO PATIENT DEATHS |
| 1.4.07 |
Trasylol® (aprotinin) – Important revisions to the WARNINGS section of Prescribing Information |
UPDATED WARNING |
| 12.19.06 |
Unapproved Drug Products Containing Quinine |
SAFETY CONCERNS, ADVERSE EVENTS INCLUDING DEATHS |
| 12.18.06 |
Compounded Topical Anesthetic Creams |
CAN CAUSE SEIZURES, IRREGULAR HEARTBEATS & DEATH |
| 12.12.06 |
Heparin Sodium Injection |
UPDATED WARNINGS: RISK OF HIT |
| 12.6.06 |
Dolophine (Methadone Hydrochloride) |
REPORTS OF DEATH & LIFE-THREATENING ADVERSE EVENTS |
| 11.28.06 |
Erythropoiesis Stimulating Agents (ESA) |
CLINICAL STUDY RESULTS: INCREASED RISK FOR SERIOUS CARDIOVASCULAR COMPLICATIONS |
| 11.14.06 |
Concomitant Use of Ibuprofen and Aspirin |
MAY REDUCE CARDIO PROTECTION & STROKE PREVENTION |
| 10.26.06 |
Cymbalta® (duloxetine hydrochloride) Delayed-Release Capsules , Effexor® (venlafaxine hydrochloride) Tablets and Effexor XR® (venlafaxine hydrochloride) Extended- Release Capsules |
UPDATED PRESCRIBING INFORMATION |
| 9.13.06 |
Human Tissues Recovered by Donor Referral Services (DRS) and Potential Risks of Infectious Disease Transmission |
INCREASED RISK OF INFECTIOUS DISEASE TRANSMISSION |
| * AlloSource Statement |
| 9.5.06 |
Tequin (gatifloxacin) |
UPDATED PRESCRIBING INFORMATION |
| 9.5.06 |
Cipro I.V. (ciprofloxacin) for Intravenous Infusion, Cipro (ciprofloxacin hydrochloride) Tablets, Cipro (ciprofloxacin) Oral Suspension, Cipro XR (ciprofloxacin extended-release tablets) |
UPDATED PRESCRIBING INFORMATION |
| 4.25.06 |
Blackstone Medical ICON Modular Fixation System |
RECALL |
| 3.8.06 |
Cefazolin |
RECALL |
| 3.8.06 |
BioMedical Tissue Services, Ltd., Human Tissue |
CONTAMINATION Potential |
| 3.2.06 |
Mobic |
UPDATED PRESCRIBING INFORMATION
|
| 3.2.06 |
Paxil and generic paroxetine |
UPDATED PRESCRIBING INFORMATION
|
| 3.2.06 |
Relafen |
UPDATED PRESCRIBING INFORMATION |
| 12.5.05 |
Aranesp |
UPDATED PRESCRIBING INFORMATION |
| 12.5.05 |
Epogen
Procrit |
UPDATED PRESCRIBING INFORMATION |
| 11.22.05 |
Avinza |
UPDATED PRESCRIBING INFORMATION |
| 11.22.05 |
Cymbalta |
UPDATED PRESCRIBING INFORMATION |
| 6.16.05 |
Able Laboratories Drugs |
RECALL
|
| 5.16.05 |
MRI-caused injuries in patients with Implanted Neurological Simulators |
NOTIFICATION with recommendations for PREVENTION |
| 4.11.05 |
Bextra |
WITHDRAWAL |
| 4.11.05 |
NSAIDS |
RE-LABELING |
| 10.24.03 |
Universal Protocol for Preventing Wrong Site, Wrong Procedure,Wrong Person Surgery |
NASS ENDORSES PROTOCOL
|
| 3.8.03 |
Procrit |
COUNTERFEIT Product Warning
|
| 8.29.02 |
Cryolife Human Tissue |
RECALL ordered by FDA
|